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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Origin Hip Stem - 09348215051587

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1301
In Commercial Distribution

  • 09348215051587 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051570

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1201
In Commercial Distribution

  • 09348215051570 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051563

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1101
In Commercial Distribution

  • 09348215051563 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051556

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1001
In Commercial Distribution

  • 09348215051556 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051549

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0901
In Commercial Distribution

  • 09348215051549 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051532

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1800
In Commercial Distribution

  • 09348215051532 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051525

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1600
In Commercial Distribution

  • 09348215051525 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051518

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1500
In Commercial Distribution

  • 09348215051518 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051501

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1400
In Commercial Distribution

  • 09348215051501 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051495

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1300
In Commercial Distribution

  • 09348215051495 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051488

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1200
In Commercial Distribution

  • 09348215051488 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051471

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1100
In Commercial Distribution

  • 09348215051471 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051464

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1000
In Commercial Distribution

  • 09348215051464 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051457

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0900
In Commercial Distribution

  • 09348215051457 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051440

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0800
In Commercial Distribution

  • 09348215051440 ()


  • Coated femoral stem prosthesis, modular

SJM™ - 05414734007276

With EnCap Technology
ST. JUDE MEDICAL, INC.
C0914
In Commercial Distribution

  • 05414734007276 ()

  • Length: 14 Centimeter
  • Width: 9 Centimeter
C0914

  • Cardiovascular patch, animal-derived

SJM™ - 05414734007269

With EnCap Technology
ST. JUDE MEDICAL, INC.
C0510
In Commercial Distribution

  • 05414734007269 ()

  • Length: 10 Centimeter
  • Width: 5 Centimeter
C0510

  • Cardiovascular patch, animal-derived

SJM™ - 05414734007252

With EnCap Technology
ST. JUDE MEDICAL, INC.
C0205
In Commercial Distribution

  • 05414734007252 ()

  • Width: 2 Centimeter
  • Length: 5 Centimeter
C0205

  • Cardiovascular patch, animal-derived

SJM™ - 05414734054881

Pericardial Patch
ST. JUDE MEDICAL, INC.
C0405
In Commercial Distribution

  • 05414734054881 ()

  • Length: 5 Centimeter
  • Width: 4 Centimeter
C0405

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818696

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0406
In Commercial Distribution

  • 00085412818696 ()
SPG0406

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818672

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0404
In Commercial Distribution

  • 00085412818672 ()
SPG0404

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818658

PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG1225
In Commercial Distribution

  • 00085412818658 ()
PG1225

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818634

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG02515
In Commercial Distribution

  • 00085412818634 ()
VG02515

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818610

PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG1016
In Commercial Distribution

  • 00085412818610 ()
PG1016

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818597

PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0814
In Commercial Distribution

  • 00085412818597 ()
PG0814

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818573

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0209
In Commercial Distribution

  • 00085412818573 ()
VG0209

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818559

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG01510
In Commercial Distribution

  • 00085412818559 ()
VG01510

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818535

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0114
In Commercial Distribution

  • 00085412818535 ()
VG0114

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818511

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0110
In Commercial Distribution

  • 00085412818511 ()
VG0110

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818498

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0108
In Commercial Distribution

  • 00085412818498 ()
VG0108

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818474

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0106
In Commercial Distribution

  • 00085412818474 ()
VG0106

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818443

PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0608
In Commercial Distribution

  • 00085412818443 ()
PG0608

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818429

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG1016
In Commercial Distribution

  • 00085412818429 ()
SPG1016

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818405

PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0404
In Commercial Distribution

  • 00085412818405 ()
PG0404

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818375

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0814
In Commercial Distribution

  • 00085412818375 ()
SPG0814

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818313

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0608
In Commercial Distribution

  • 00085412818313 ()
SPG0608

  • Cardiovascular patch, animal-derived

VASCU-GUARD Peripheral Vascular Patch - 00085412530925

VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0209N
In Commercial Distribution

  • 00085412530925 ()
VG0209N

  • Cardiovascular patch, animal-derived

VASCU-GUARD Peripheral Vascular Patch - 00085412530918

VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0110N
In Commercial Distribution

  • 00085412530918 ()
VG0110N

  • Cardiovascular patch, animal-derived

VASCU-GUARD Peripheral Vascular Patch - 00085412530895

VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0108N
In Commercial Distribution

  • 00085412530895 ()
VG0108N

  • Cardiovascular patch, animal-derived

VASCU-GUARD Peripheral Vascular Patch - 00085412530871

VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0106N
In Commercial Distribution

  • 00085412530871 ()
VG0106N

  • Cardiovascular patch, animal-derived
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